U.S. FDA registration & U.S. Agent services · Casper, Wyoming, USA info@regovant.com+1 307-301-7465
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FDA Food Facility Registration for EU Companies

Exporting olive oil, cheese, chocolate, pasta, wine and supplements from the European Union to the U.S.? Each facility that makes, packs or stores them must be registered with the U.S. FDA and name a U.S. Agent, in addition to your food business registration or approval with your national authority. We do it for $269 a year.

  • Registration filed in 1 to 5 business days once we have your details
  • U.S. Agent service in the United States included
  • Certificate of registration your U.S. buyers can verify online
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Pricing for EU companies

USD
Registration + U.S. AgentPer facility, per year$269
Additional facilitySame owner$169
Prior NoticePer shipment$25
FDA charges no fee for food registrationCard or PayPal

Do EU food companies need FDA registration?

Yes. Under U.S. law, every facility that manufactures, processes, packs or holds food for people or animals in the United States must be registered with the U.S. Food and Drug Administration. This applies to facilities in the European Union exactly as it does to U.S. facilities. Typical EU products we register include olive oil, cheese, chocolate, pasta, wine, bakery and supplements.

Your food business registration or approval with your national authority is still needed at home, but it does not replace FDA registration. Without a valid FDA registration, your shipments can be held at the U.S. port and your importer cannot file Prior Notice correctly.

What you need

  • The facility's legal name and exact physical address
  • A D-U-N-S number for that address. It is free from Dun & Bradstreet but can take several weeks, so request it early.
  • An emergency contact phone answered 24 hours a day
  • A list of the foods made, packed or stored at the facility

Allergens and labels differ

EU and U.S. labels are not interchangeable. The U.S. list of major allergens does not include celery, mustard, lupin or sulphites, U.S. labels must name the specific tree nut, fish or shellfish, and the Nutrition Facts format is different. See our label reviews.

Wine, beer and spirits

Wineries, breweries and distilleries must register with FDA too. Separately, your U.S. importer needs label approval from the Alcohol and Tobacco Tax and Trade Bureau (TTB).

EU cosmetics

A CPNP notification and an EU Responsible Person do not cover the U.S. Cosmetics sold in the U.S. need MoCRA facility registration and product listing. Most EU INCI names can be used on U.S. labels, but some differ from the names FDA requires, and sunscreens that are cosmetics in the EU are OTC drugs in the U.S. See our MoCRA registration service ($369 a year with U.S. Agent). Before you order, see who must register, how product listing works and U.S. label rules. Products with SPF are regulated as drugs in the U.S. (cosmetic or drug?).

How Regovant helps

  1. Order online and pay by card or PayPal in U.S. dollars. $269 per facility per year.
  2. Send your details through one short registration form.
  3. We check and file. We check your D-U-N-S details, file with FDA and act as your U.S. Agent.
  4. You receive your FDA registration number and a Regovant certificate of registration your buyers can verify.

Food facility registrations are renewed between October 1 and December 31 of every even-numbered year. We email you before each renewal. See the 2026 renewal guide or our step-by-step registration guide.

Questions

We are approved by our national authority. Do we still need FDA registration?

Yes. Approvals at home cover the European Union. For the U.S., each facility that makes, packs or stores the food must be registered with the U.S. FDA.

Do EU facilities need a U.S. Agent?

Yes. Every food facility outside the U.S. must name a U.S. Agent located in the United States. It is included in our $269 price.

Do you have pages for our country?

Yes, for France, Germany, Italy and Spain. The FDA rules are the same in every EU country.

Registering from another country? See FDA registration by country.